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Top news of the day from across the health care landscape.
The US Supreme Court declined an attempt by the state of Maryland to revive a law seeking to prevent pharmaceutical manufacturers from price gouging, which would have improved the ability of states to lower prescription drug costs, Reuters reported. The court ruled against taking up an appeal of a 2018 federal appeals ruling against the law on grounds that Maryland violated the US Constitution's ban on state-level regulation of interstate commerce by regulating wholesale pricing by pharma, according to the article. In a statement reported by Reuters, state representatives said that the decision not only blocks Maryland and other states from eliminating prescription drug pricing practices that harm consumers and public health, but also could jeopardize regulatory efforts in other states.
The authors of a study published in JAMA found that the FDA, physicians, and drug companies failed to adequately monitor the prescribing of powerful opioid painkillers, which caused an “alarming” number of patients to be administered fentanyl, the Washington Post reported. In a review of approximately 5000 pages of documents requested through the Freedom of Information Act, the researchers found that the FDA and drug companies did not take action to halt the distribution of fentanyl in patients who should have been ineligible for the powerful opioid under safeguards in place to restrict its use, the article reported. “The whole purpose of this distribution system was to prevent exactly what we found,” Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness, said in the report.
The FDA cautioned consumers against the use of plasma infusions from young blood donors to mitigate the effect of normal aging and other more serious conditions, CNN reported. Plasma, which can treat bleeding and clotting abnormalities, has potential benefits in trauma care and other settings; however, the infusions were being promoted to treat conditions such as dementia, multiple sclerosis, heart disease, and post-traumatic stress disorder, according to the report. "There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat, or prevent these conditions, and there are risks associated with the use of any plasma product," FDA Commissioner Scott Gottlieb, MD, said in a statement. "The reported uses of these products should not be assumed to be safe or effective." The FDA is discouraging the use of plasma, "outside of clinical trials under appropriate institutional review board and regulatory oversight."
FDA Approves Bimekizumab-Bkzx as Treatment for Hidradenitis Suppurativa